Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation; Cataract
• Intervention / Treatment: Drug: Loteprednol Etabonate Gel (BID); Drug: Vehicle (BID); Drug: Loteprednol Etabonate Gel (TID); Drug: Vehicle (TID)

Detailed Description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Visit 1 (Screening Visit)

• Be willing and able to comply with all treatment and follow-up/study procedures.
• Be a candidate for routine, uncomplicated cataract surgery

Visit 3 (Postoperative Day 1)

• Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
• Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

• Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
• Have known hypersensitivity or contraindication to the study drug(s) or their components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel 0.38% administered two times daily (BID).	Drug: Loteprednol Etabonate Gel (BID); One drop of LE gel instilled into the study eye two times per day (BID) for 14 days; Other Names: Lotemax
Active Comparator: Vehicle (BID); Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID).	Drug: Vehicle (BID); One drop of vehicle instilled into the study eye two times per day (BID) for 14 days; Other Names: Vehicle
Experimental: Loteprednol Etabonate Gel (TID); Loteprednol Gel 0.38% administered three times daily (TID).	Drug: Loteprednol Etabonate Gel (TID); One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.; Other Names: Lotemax
Active Comparator: Vehicle (TID); Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).	Drug: Vehicle (TID); One drop of vehicle instilled into the study eye three times per day (TID) for 14 days; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.	8 days
Percentage of Participants With Grade 0 Pain in the Study Eye.	Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.	18 days
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.	18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.	Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.	18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).	18 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Jon I Williams, PhD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 842

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No